Hepatitis CEarly Phase 1CUTTS HepCNCT06159504
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
A Early Phase 1 study testing sofosbuvir/velpatasvir (SOF/VEL) and Shortened read time of rapid diagnostic test for hepatitis C virus. in people with Hepatitis C and RDT, run by Médecins du Monde at 1 site in Armenia.
Trial summary
The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, RDT
- What is being tested?
- sofosbuvir/velpatasvir (SOF/VEL) and Shortened read time of rapid diagnostic test for hepatitis C virus.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,040 participants
- Where
- 1 siteArmenia
- Study dates
- 3 Oct 2024to Dec 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able and willing to provide informed consent in local language
- Not currently on or previously had treatment for hepatitis C
- Attending site for needle / syringe program, OR self-reports ever injecting drugs
Who cannot join
- Self-reported history of decompensate cirrhosis of the liver
- Women who are pregnant or breast-feeding
- Self-report other significant co-morbidities such as uncontrolled HIV infection, history of renal dysfunction, tuberculosis infection, or chronic hepatitis B infection
- Unable / unwilling to stop any contraindicated medications / supplements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Margaret Hellard contact
Armenia1 site, 1 recruiting
- Recruiting
National Institute for Infectious Diseases
Yerevan
Dr. Sargsyan, sargsyanqn30@gmail.com
Knarik Dr. Sargsyan
About this study
Official title: Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial
The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania.
The main questions it aims to answer are:
Read more
- What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries?
- Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test?
- What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody/confirmatory RNA test) model?
Participants will:
- be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2)
- if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.
- if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.
Researchers will compare cure and participant retention rates between the two groups.
Read the detailed description
The investigators will conduct a study to trial a new, simplified, and lower cost clinical pathway and determine its feasibility, effectiveness, cost-effectiveness and acceptability in Armenia, Georgia, and Tanzania.
This is a non-randomised, quasi-experimental, prospective comparative trial with approximately 350 participants initiated onto hepatitis C treatment in each arm. Arm one is a simplified care model (following global guidance) with hepatitis C treatment commencing after a rapid hepatitis C antibody test and a confirmatory positive hepatitis C ribonucleic acid (RNA) test. Arm two will involve same day treatment commencement following a positive rapid antibody test without confirmatory RNA testing prior to treatment initiation (RNA testing will be completed after treatment is provided). In arm two, the decision to treat will be based on the result of an early read time (< 5 mins) of a rapid antibody test which previous research findings suggest correlates strongly with a hepatitis C RNA positive test result. All positive participants will be treated with sofosbuvir (400mg) and velpatasvir (100mg), self-administered orally once per day for 12 weeks. Hepatitis C cure will be assessed by sustained virological response (SVR) laboratory testing.
The first primary outcome is feasibility, measured throughout the care cascade. Primary outcomes compared across the two arms will be the proportion of participants 1) commencing treatment and 2) achieving SVR. Test concordance and validity of the early read time will be assessed against laboratory RNA test results (which will also guide decisions to continue or cease treatment in Arm 2). A mixed effects model will be used to assess study outcomes and infectious diseases modelling will determine cost-effectiveness. The acceptability and feasibility of the models will be assessed through thematic analysis of participant and practitioner interviews, and site assessments.
- Conditions
- Hepatitis C, RDT
- Being tested
- sofosbuvir/velpatasvir (SOF/VEL), Shortened read time of rapid diagnostic test for hepatitis C virus.
- Keywords
- Point of care (PoC), Nucleic acid testing, Qualitative interviews, Feasibility, Acceptability, Cost-effectiveness, Modelling
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir/velpatasvir (SOF/VEL)Drug
400mg of SOF and 100mg of VEL self administered daily as a tablet.
Shortened read time of rapid diagnostic test for hepatitis C virus.Diagnostic test
Also called OraQuick® HCV RDT
Administered once during hepatitis C testing. Test is read after 5 minutes rather than its usual time of 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - simplified care model | Active comparator | Arm 1 will receive DAA medication at the second appointment following the return of RNA HCV results. They will receive sofosbuvir (400mg) and velpatasvir (100mg). Receives: Drug: sofosbuvir/velpatasvir (SOF/VEL) |
| Arm 2 - short read time | Experimental | Arm 2 will begin DAA treatment after the first appointment following a shortened RDT read time of 5 minutes rather than 20 minutes. They will receive sofosbuvir (400mg) and velpatasvir (100mg). Receives: Drug: sofosbuvir/velpatasvir (SOF/VEL); Diagnostic Test: Shortened read time of rapid diagnostic test for hepatitis C virus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of implementing a hepatitis C simplified care (Arm 1) and same-day treatment (Arm 2) care models in community and harm reduction settings in the three study countries.
Measured through case report forms, interviews and study site checks.
Measured: 3 years
The proportion of participants initiating hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
Measured: 3 years
The proportion of participants who achieve SVR following hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
Measured: 3 years
The comparative cost and cost-effectiveness of simplified care vs same-day treatment models of care.
Measured: 3 years
Secondary outcomes (7)
Participant acceptability of the hepatitis C simplified care and same-day treatment care models.
Measured through interviews and surveys
Measured: 3 years
Practitioner acceptability of hepatitis C simplified care and same-day treatment care models
Measured through interviews
Measured: 3 years
The time to treatment initiation among participants in simplified care Arm vs same-day treatment Arm
Measured: 3 years
The proportion of participants who complete hepatitis C treatment in simplified care Arm vs same-day treatment Arm
Measured: 3 years
The proportion of participants whose hepatitis C antibody test result at 5-min read-time concords with RNA test results.
Measured: 3 years
Identification of the optimal "cut-off" read-time for hepatitis C antibody test to predict RNA positivity
Measured: 3 years
The proportion of participants "overtreated" for hepatitis C in the same-day treatment Arm.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start3 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups will be running in tandem/parallel to one another at the same time.
- Masking
- None (open label)
- Enrolment
- 3,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Médecins du Monde
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID, Burnet Institute, University of Bristol, International Network of People who Use Drugs
- Responsible party
- Sponsor
- Investigators
- Margaret Hellard, Principal investigator, Burnet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159504
- Sponsor's protocol ID
- CUTTS HepC / HCV MoC
- Acronym
- CUTTS HepC
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Draper BL, Flynn M, Schroeder S, Wisse E, Aikaeli F, Han ZM, Ayako M, Bajis S, Butsashvili M, Davtyan K, Kordzadze T, Lamand P, Luhmann N, Sargsyan K, Senkoro M, Scott N, Stone J, Vickerman P, Voloshin A, Walker J, Madden A, Stoove MA, Hellard M, Pedrana A; CUTTS HepC Consortium, Hepatitis C Models of Care Study Team. Non-randomised trial of a hepatitis C same-day test and treat model using antibody test only for people who inject drugs in Armenia, Georgia and Tanzania: a CUTTS HepC study protocol. BMJ Open. 2026 Mar 24;16(3):e114119. doi: 10.1136/bmjopen-2025-114119.
PubMed 41876153